@quanzi Yes, and "difficulty" of a medical device project has a number of facets to it.  There's financial difficulty, technological difficulty, clinical difficulty, and others.

I have not been involved in building a new school or skyscraper per se, but I have been involved in building new hospitals and expansion of hospital campuses.  The project management for architectural structures have much greater certainty than project management for medical devices, where one is attempting to build the "unknown" by re-imagining an existing process or responded to a heretofore unmet need.  The project management teams for building a new hospital are generally much larger in scale than the relatively small teams devoted to designing a new medical device.  Although a hospital might include new intricacies in its design that includes a plethora of medical devices, the project itself is a product of a long-term strategic plan and it is replete with so many more layers.  By certainty, I mean that the hospital knew what building permits, zoning parameters, political maneuvers, manpower, contracts and real estate needed to be acquired in advance of actual construction 3-5 years later. 

I would like to think that medical device development is more organic than building a hospital, and it is more central to responding genuine medical needs, an antithesis to the iPhone model of delaying and switching cell phone features to manipulate consumer demand.  Medical device development has a unique higher degree of risk than the construction of a building.  Yes, hospital construction is an enormous investment which has a project cycle with clearly defined milestones, a beginning and an end, the requirement to be on-time and within budget.  However, the medical device development requires the testing and completion of a device, plus the challenges of creating a sound repetitive process to efficiently manufacture and distribute to hospitals and a whole host of players in the healthcare industry. For example, trial and error testing/research and development are likely to be a fundamental step in the project management of a new medical device development and quality control measures will have to be developed, whereas in building construction, the standards of quality are already established.

There are many differences between managing projects of medical devices and those of building schools or skyscrapers. 

For medical devices, the execution phase is more elaborate as more testing and a huge number of clinical trials are required, whereas for the civil projects more time goes into the planning phase to make sure the architectural design is sturdy and usable.

The deadlines for medical device projects might be a lot tighter than the other projects as the time required to get the product out and running in the market due to the competition is limited as compared to having a new skyscraper.

The regulatory considerations of each country developing the medical device product and also meeting the standards of FDA/ CE based on their requirements and the market they are focussing on is a very obvious difference.  Such regulatory considerations are not required for civil projects. 

The closing phase is very elaborate as well for medical devices as a lot more approvals and compliances are required before the product can be sent out into the market.

I think project management of medical devices has some few unique aspects in relation to other types of projects. i would like to discuss three areas; product complexity, uncertainty and risk/product liability.

Medical devices are becoming more complex with regards to their applications. Whether they are implanted or external to the body, the complexity can be seen in developing diverse product requirements, implementing design meeting diverse usage or individuals, selecting new materials of construction, costs and meeting regulatory requirements.  

Secondly, medical devices can have uncertainty which needs to be managed through out the project life-cycle. Uncertainty can manifest itself in not fully understanding the problems changing product requirements overtime, payor/paying system supporting the product and ultimately end user acceptance.   

Finally, medical devices have significant risk for organizations with a high level of product liability. During all phases of the project, PM and the project team need to evaluate the risk associated with the medical device. In the Initiation phase does the business case present the revenue opportunity as well as the potential upside and downside with respect to return on investment. In the planning phase, did the project team have covered all items for the project, if not, risks will increase. in the design phase, selecting unproven approaches to materials, manufacturing processes, interaction with patients or users can also be risky. 

I believe a great challenge in being a project manager in medical devices as opposed to being a project manager in building a skyscraper is the fact that the medical device industry is very susceptible to pandemics and new diseases. Particularly during the covid19 crisis, the project managers for medical devices most likely had to switch gears and truly needed to adopt flexibility. Thus, the unpredictable nature of human diseases and viruses pose a great challenge. On the other hand, a project manager working on the development of a skyscraper is not as severely affected by such pandemics. A major concern for project managers in the skyscraper business may be the weather, which can be predicted to a degree, but a human virus outbreak is not as easily predictable and would likely cause a halt in many medical device projects. 

Challenges in project management for medical devices would be the rules outlined by regulatory bodies. Many people have mentioned that the FDA imposes the greatest challenge to project managers, however I would add that the FDA equivalent in other countries, such as EMA, Health Canada and NMPA exponentially increase the responsibility of PMs. As one might expect, the regulations imposed by each country vary, some more so than others. The recent changes in Europe which shifts to a more comprehensive and lengthy submission process as well as China's decision to change requirements for products sold/manufactured outside of China. In this instance Europe requirements a heavier hand when it comes to proving safety while China can be perceived as "relaxing" requirements. While it is obviously "easier" for companies to move through less stringent regulations, it poses a unique situation for project management who need to understand each set of rules for the countries they choose to sell to. In my opinion, the only way to eliminate this problem would be to unify the worlds regulation of medical devices which is more than unlikely to happen. What are you thoughts on the unification of medical device regulation globally.

I agree with the previous post from Anthony that unification of medical device regulations globally could drastically help project managers that are managing devices entering many different markets. However, I also agree that this is very unlikely to happen. I do not think regulations will be unified due to history and cultural differences. Furthermore requirements are similar to laws and are subject to interpretation and this interpretation may differ drastically depending on region. For example, there are strict requirements regarding IFUs for medical devices in some region. However in other regions these regulations are not as stringent as it could be considered insulting to the culture to receive a product with an IFU especially for a class I medical device. In this case, an electronic IFU or other documentation may be enough to satisfy the requirement, whereas in other regions this would not suffice. Due to these differences I do not think to harmonize regulations globally. 

Since there are such different medical device requirements that exist depending on region, when different markets are involved there is another level of complexity added to the project. For example, if a program manager is working on a medical device that is going to be launched in both the United States and Japan, both the US and Japan requirements and markets need to be analyzed carefully. This analysis would affect the inputs of the project. Additionally, the time difference adds complexity to the program management of this kind of project with multiple markets. The language barrier could also hinder communication. 

When comparing project management for medical devices to that of project management for building schools or skyscrapers, you will find similarities and differences in how the jobs are handled and executed. I think there are more similarities in the two than differences. The planning and execution of the product have to be well thought out. The product has to usable, efficient, and last long term. Medical devices are crucial in the healthcare industry to sustain life and can have rigorous testing and protocols that need to be followed before they can reach the market. For buildings and skyscrapers, the layout is usually one size fits all model and can be done by trained professionals, while it does have protocols that need to be followed and specific codes to a habitable structure. The details and precision are not as concise as making medical devices. Some other key differences are that when making medical devices, companies and teams go through other challenges with competitors and meet a specific deadline to have a product ready and approved. These aren't many issues a project manager has for a construction site. Most managers are hired because the builder has secured them from other competitors to oversee their build and are expected to meet a deadline. The deadlines can be similar but are more pressing matters for medical devices if a design/development were to not work the way it was intended or have faults that could not allow the device to be approved for market. 

Project management is a paradigm across all projects whether it incorporates every step at each level or not, the flow is similar overall.  There is a diagram that displays the flow of the project lifecycle and the steps of management. Where there are challenges for both building a school or skyscraper as well as creating medical devices the differences of those challenges can be dissected and explored along with the diagram.

A project manager for building a school or skyscraper will have to adhere to all the safety codes and city ordinances that govern those types of projects. Obtaining permits and site approvals, funding, and contracts involve local and state government so at each of the stages there would be some challenges to coordinate and flow through the process.

The Executing flow is the one I want to discuss as it is throughout the lifespan of the project. Major points to pull out is that the execution phase involves many moving parts and for the medical devices it involves federal regulatory participation and cooperation between the developer, company, and final marketing and usefulness to the public. As a result of the high regulatory project, it involves extensive risk analysis, quality testing, and release of financial resources in addition to the intellectual property i.e., patents and timing all these critical pieces is truly a challenge.   

I think project management for medical devices is more challenging than for building a school because on top of all the regular rules and regulations, medical devices have other regulatory agencies looking at them as well.

For FDA approval of medical devices, the devices are grouped into classes depending on the level of control needed to provide reasonable assurance, with the regulatory controls increasing as the classes get higher. Medical devices also have to go through pre-clinical stages with prototype development and testing, as well as go through clinical trials, and premarket approvals. The FDA approval process can take a week, or it can take 8 months depending on the pathway taken. Studies even show that it can take from 3 – 7 years in total from concept of the idea to approval of the device. I think a challenge with medical device project management, is trying to map out a budget for the approval process, without running out of financial resources to hold the project over until approved. The medical device doesn’t make any money until approved for market as well. With the process length being unpredictable, I feel it can be a very challenging task. Having to make adjustments depending on feedback from the FDA, can be challenging as well depending on the initial budget.

@takward You make a valid point about the budget and challenges of FDA approval. Do you think things will change at any point with the process of FDA approval in the area of medical devices as we have seen the shift within vaccine pre-approval in this Covid-19 pandemic?  

@alexbryant-harden You highlighted a very important component in the medical devices industry is the competition. "Some other key differences are that when making medical devices, companies and teams go through other challenges with competitors and meet a specific deadline to have a product ready and approved." The competition aspect is a slippery slope in some cases. As you stated that challenge is basically a nonfactor once a company has secured the bid and contract to build. However, companies and employees on the cutting edge of technology are playing for the win and it's tricky. I noticed recently that a CEO/ at a division in a pharmaceutical/medical device company had been hired and then a few months later became CEO at the competitor's company.  Times have changed and people are not loyally staying at one company until retirement. Do you think companies should create incentives for employees to not abort and take their knowledge and expertise to competitors? 

I think one of the biggest challenges for project management for medical devices would be all the FDA rules and regulations that are in place. A project manager of a building or medical device both must go through the distinct phases of completing the project. A project manager for a medical device must map out the detail requirements for scheming, developing, authenticating and validation of the product prior to its transfer for manufacturing. This can be accomplished through risk management throughout the project’s lifecycle. The FDA approval process can be challenging as well as the FDA could deny the medical device and then the team must make revisions and try for approval again. Medical devices also must go through the pre-clinical stages whereas building a school does not. Both have their own set of challenges, however project managers for medical devices have a few more challenges to overcome than project managers for a building.

The acquisition of a constructed facility usually represents a major capital investment, whether its owner happens to be an individual, a private corporation, or a public agency. Since the commitment of resources for such an investment is motivated by market demands or perceived needs, the facility is expected to satisfy certain objectives within the constraints specified by the owner and relevant regulations. With the exception of the speculative housing market, where the residential units may be sold as built by the real estate developer, most constructed facilities are custom-made in consultation with the owners. A real estate developer may be regarded as the sponsor of building projects, as much as a government agency may be the sponsor of a public project and turns it over to another government unit upon its completion. From the viewpoint of project management, the terms "owner" and "sponsor" are synonymous because both have the ultimate authority to make all important decisions. Since an owner is essentially acquiring a facility on a promise in some form of agreement, it will be wise for any owner to have a clear understanding of the acquisition process in order to maintain firm control of the quality, timeliness, and cost of the completed facility. From the perspective of an owner, the project life cycle for a constructed facility may be illustrated schematically. Essentially, a project is conceived to meet market demands or needs in a timely fashion. Various possibilities may be considered in the conceptual planning stage, and the technological and economic feasibility of each alternative will be assessed and compared in order to select the best possible project. The financing schemes for the proposed alternatives must also be examined, and the project will be programmed with respect to the timing for its completion and for available cash flows. After the scope of the project is clearly defined, a detailed engineering design will provide the blueprint for construction, and the definitive cost estimate will serve as the baseline for cost control. In the procurement and construction stage, the delivery of materials and the erection of the project on-site must be carefully planned and controlled. After the construction is completed, there is usually a brief period of start-up or shake-down of the constructed facility when it is first occupied. Finally, the management of the facility is turned over to the owner for full occupancy until the facility lives out its useful life and is designated for demolition or conversion.